PA09 Exploring the potential impact of adhering to the Medicines and Healthcare products Regulatory Agency ‘introduction of new safety measures for isotretinoin’ guidelines (October 2023)

Abstract Acne is an inflammatory skin condition and a common dermatology referral in the UK. Isotretinoin is recommended in the National Institute for Health and Care Excellence guidelines for severe forms of acne in those aged > 12 years. In October 2023 new guidance was published to ensure patients were informed and monitored effectively during isotretinoin treatment. We audited adherence to key points of this guidance and considered the potential impact on the provision of dermatology services in our trust. All patients were included who started on isotretinoin over an 8-month period (February to October 2024). Clinical letters and electronic patient records were used to collect data. In total, 196 patients (89 male, 107 female) were included, with an average age of 21 years at first appointment. Overall, 99% (194 of 196) had formal mental health assessment prior to starting isotretinoin, while 41% (81 of 196) were specifically asked about sexual function concerns. Most (96%, 76 of 79) of those aged < 18 years had a documented second prescriber. In 68% (134 of 196) the acknowledgement-of-risk form was fully complete. Overall, 97% (179 of 184) had a face-to-face first review, with an average of 34 days following treatment initiation. At follow-up 95% (174 of 184) had mental health assessments recorded and 67% (124 of 184) had documented discussion of sexual function side-effects. Services changed considerably to adhere to the new guidance. Previously, this was a telephone service led by a band 6 clinical nurse specialist. Now band 8 nurses and above are required to initiate treatment in person, using in-demand clinical consultation rooms. Despite covering a large geographical area with multiple peripheral sites, services were centralized to one site. The requirement of face-to-face appointments meant the average distance travelled per appointment was 21.6 miles. We estimated that over an 8-month period, 8570 miles were travelled to attend appointments, producing 4.8 metric tons of carbon dioxide. In-person appointments also increase parents’ and patients’ time off work and school. We timed completion of the additional requirements, which are summarized in the Table. For a female paediatric patient this could add as much as 23.5 min, the equivalent of a new outpatient dermatology appointment. While our study highlights that our department has adhered well to the new guidance, it also shows that this has had potential costs on the provision of services and hinders our approach to deliver sustainable healthcare. With long waiting lists across dermatology departments, we question the appropriateness of these guidelines in providing a well-rounded dermatological service that serves our entire patient population.TableAdditional time for appointments Time (min)Dermatology Life Quality Index2Patient Health Questionnaire -93General Anxiety Disorder-72Male acknowledgement-of-risk form9.5Female acknowledgement-of-risk form11Second prescriber7.5Scanning and uploading eight sheets to patient record4